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Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors

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ClinicalTrials.gov Identifier: NCT00445757
Recruitment Status : Withdrawn (slow accrual)
First Posted : March 9, 2007
Last Update Posted : March 20, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors.


Condition or disease Intervention/treatment Phase
Kidney Cancer Procedure: conventional surgery Radiation: stereotactic radiosurgery Phase 1

Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of radiation in patients undergoing stereotactic radiotherapy for renal tumors.
  • Determine radiotherapy-associated toxicity in these patients.

Secondary

  • Determine preoperative pathologic response to this regimen in these patients.

OUTLINE: This is a dose-escalation study of radiotherapy.

  • Radiotherapy: Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached. The MTD is defined as the dose preceding that at which at least 2 of 4 or 3 of 8 patients experience dose-limiting toxicity (DLT). DLT is assessed at 4 and 8 weeks after radiotherapy.
  • Surgery: Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.

After completion of study therapy, patients are followed periodically for at least 2 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors
Study Start Date : January 2007
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Procedure: conventional surgery
    Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.
    Radiation: stereotactic radiosurgery
    Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached.

Outcome Measures

Primary Outcome Measures :
  1. Maximum tolerated dose of radiation [ Time Frame: DLT is assessed at 4 and 8 weeks after radiotherapy ]
  2. Radiotherapy-associated toxicity [ Time Frame: DLT is assessed at 4 and 8 weeks after radiotherapy ]

Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery ]
  2. Time to local progression [ Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery ]
  3. Time to distant failure [ Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery ]
  4. Survival [ Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery ]
  5. Disease-specific survival [ Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Radiologically confirmed renal tumor

    • At least 4 cm in greatest dimension
  • No clinically, radiologically, or pathologically involved lymph nodes
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Medically eligible for tumor resection
  • No major medical condition or psychiatric illness that would preclude study compliance
  • No active connective tissue disease, such as lupus or dermatomyositis
  • No active Crohn's disease or active ulcerative colitis

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior abdominal or pelvic radiotherapy
  • No prior cryosurgery
  • No prior radiofrequency ablation
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445757


Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lee E. Ponsky, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00445757     History of Changes
Other Study ID Numbers: CASE5806
P30CA043703 ( U.S. NIH Grant/Contract )
CASE5806 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Keywords provided by Case Comprehensive Cancer Center:
stage I renal cell cancer
stage II renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type